This is the first randomized study to demonstrate a radiographic
progression-free survival benefit and an overall survival trend in
this patient population. The COU-AA-302 results are being presented
at the 48th Annual Meeting of the American Society of Clinical
Oncology (ASCO).

"These results are very promising for abiraterone acetate in the
treatment of patients with metastatic castration-resistant prostate
cancer who are asymptomatic or mildly symptomatic and have not
received chemotherapy. The results also advance our understanding
of the role of androgen biosynthesis inhibition in this patient
population," said Charles J. Ryan, M.D., lead investigator of the
study and Associate Professor of Clinical Medicine at the UCSF
Helen Diller Family Comprehensive Cancer Center. "This is an
important study with all clinically relevant endpoints favoring
treatment with abiraterone acetate plus prednisone, and is also the
first to suggest that inhibiting androgen production significantly
delays initiation of cytotoxic chemotherapy."

The data demonstrate a statistically significant improvement in
rPFS in the abiraterone acetate plus prednisone arm (ZYTIGA arm) of
the study compared to the placebo plus prednisone (control) arm.
The median rPFS in the control arm was 8.3 months but had not yet
been reached in the ZYTIGA arm because progression events were
occurring more slowly in the ZYTIGA arm compared to the control arm
(N=150 vs. 251, respectively). The Hazard Ratio (HR) equaled 0.43,
there was a 95% confidence interval (CI): [0.35, 0.52], and the
p-value was <0.0001.

Additionally, treatment with ZYTIGA plus prednisone resulted in
an estimated 33 percent improvement in survival (median overall
survival in the ZYTIGA arm was not reached and was 27.2 months in
the control arm; HR=0.75; 95% CI: [0.61, 0.93], p=0.0097). At the
time of these interim analyses, the pre-specified p-value of 0.0008
to achieve statistical significance was not reached.

Median time to opiate use for cancer pain: the median time in
the ZYTIGA arm was not reached and was 23.7 months in the control
arm (HR=0.69; 95% CI: [0.57, 0.83]; p=0.0001).
Median time to initiation of cytotoxic chemotherapy for prostate
cancer: 25.2 months for the ZYTIGA arm vs. 16.8 months for the
control arm (HR=0.58 [95% CI: 0.49, 0.69]; p<0.0001).
Median time to deterioration in performance status: 12.3 months for
the ZYTIGA arm vs. 10.9 months for the control arm (HR=0.82; 95%
CI: [0.71, 0.94]; p=0.0053) for an increase in the Eastern
Cooperative Oncology Group (ECOG) performance score of one point or
more. The ECOG performance score is a standard measure used to
assess functional status of a patient and is often used to
determine prognosis and appropriate treatment.
Median time to PSA progression: 11.1 months for the ZYTIGA arm vs.
5.6 months for the control arm (HR=0.49; 95% CI: [0.42, 0.57],
p<0.0001), based on The Prostate Cancer Clinical Trials Working
Group (PCWG2) criteria.
Safety Findings
Patients in the ZYTIGA arm of the study experienced more grade 3
and grade 4 adverse events than those in the control arm, including
cardiac disorders (6% vs. 3%) and hypertension (4% vs. 3%), as well
as increases in alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) (5.4% vs. 0.8% and 3.0% vs. 0.9%,
respectively). Fatigue was the most common adverse event observed
in the study.

Based on these results, Janssen plans to submit marketing
applications with regulatory authorities to extend the use of
ZYTIGA in men with mCRPC who have not received chemotherapy,
beginning in the second half of 2012.

"These results further suggest evidence of the important
clinical benefit of ZYTIGA for men with metastatic
castration-resistant prostate cancer," said William N. Hait, M.D.,
Ph.D., Global Head, Janssen Research & Development and Head,
Oncology Therapeutic Area. "The COU-AA-302 study expands our
understanding of the utility of treating this disease with ZYTIGA,
and is central to our goal of developing extraordinary oncology
therapeutic solutions that can have a positive effect on patients'
lives."

Janssen Research & Development previously announced that an
Independent Data Monitoring Committee (IDMC) unanimously
recommended unblinding this Phase 3 study after planned interim
analyses found a statistically significant difference in rPFS and a
trend in the difference in OS. Based on these results, the IDMC
also recommended that patients in the control arm be offered
treatment with abiraterone acetate.

About ZYTIGA
Since its first approval in the U.S. in 2011, ZYTIGA has been
approved in more than 45 countries. Many thousands of men have
received treatment with it, and it is quickly becoming one of the
cornerstones of treatments for mCRPC.

ZYTIGA in combination with prednisone was approved by the U.S.
Food and Drug Administration (FDA) in April 2011 for the treatment
of men with mCRPC who have received prior chemotherapy containing
docetaxel. The Phase 3 study for this initial ZYTIGA indication was
also unblinded after review of a pre-specified interim analysis and
recommendations from the IDMC, in August 2010, based on a
statistically significant improvement in median OS and an
acceptable safety profile. A subsequent analysis with more mature
data confirmed the survival benefit and safety profile.

More information about ZYTIGA can be found at
www.zytiga.com.

Indication
ZYTIGA® (abiraterone acetate) in combination with prednisone is
indicated for the treatment of patients with metastatic
castration-resistant prostate cancer (CRPC) who have received prior
chemotherapy containing docetaxel.

Important Safety Information
Contraindications - ZYTIGA® (abiraterone acetate) may cause
fetal harm (Pregnancy Category X) and is contraindicated in women
who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to
Mineralocorticoid Excess - Use with caution in patients with a
history of cardiovascular disease or with medical conditions that
might be compromised by increases in hypertension, hypokalemia, and
fluid retention. ZYTIGA® may cause hypertension, hypokalemia,
and fluid retention as a consequence of increased mineralocorticoid
levels resulting from CYP17 inhibition. Safety has not been
established in patients with LVEF <50% or New York Heart
Association (NYHA) Class III or IV heart failure because these
patients were excluded from the randomized clinical trial. Control
hypertension and correct hypokalemia before and during
treatment.

Adrenocortical Insufficiency (AI) - AI has been reported in
clinical trials in patients receiving ZYTIGA® in combination
with prednisone, after an interruption of daily steroids and/or
with concurrent infection or stress. Use caution and monitor for
symptoms and signs of AI if prednisone is stopped or withdrawn, if
prednisone dose is reduced, or if the patient experiences unusual
stress. Symptoms and signs of AI may be masked by adverse reactions
associated with mineralocorticoid excess seen in patients treated
with ZYTIGA®. Perform appropriate tests, if indicated, to
confirm AI. Increased dosages of corticosteroids may be used
before, during, and after stressful situations.

Hepatotoxicity - Increases in liver enzymes have led to drug
interruption, dose modification, and/or discontinuation. Monitor
liver function and modify, withhold, or discontinue ZYTIGA®
dosing as recommended (see Prescribing Information for more
information). Measure serum transaminases [alanine aminotransferase
(ALT) and aspartate aminotransferase (AST)] and bilirubin levels
prior to starting treatment with ZYTIGA®, every two weeks for
the first three months of treatment, and monthly thereafter.
Promptly measure serum total bilirubin, AST, and ALT if clinical
symptoms or signs suggestive of hepatotoxicity develop. Elevations
of AST, ALT, or bilirubin from the patient's baseline should prompt
more frequent monitoring. If at any time AST or ALT rise above five
times the upper limit of normal (ULN) or the bilirubin rises above
three times the ULN, interrupt ZYTIGA® treatment and closely
monitor liver function.

Food Effect - ZYTIGA® must be taken on an empty stomach.
Exposure of abiraterone increases up to 10-fold when abiraterone
acetate is taken with meals. No food should be eaten for at least
two hours before the dose of ZYTIGA® is taken and for at least
one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax
and AUC0-infinity (exposure) were increased up to 17- and 10-fold
higher, respectively, when a single dose of abiraterone acetate was
administered with a meal compared to a fasted state.

Drug Interactions - ZYTIGA® is an inhibitor of the hepatic
drug-metabolizing enzyme CYP2D6. Avoid coadministration with CYP2D6
substrates that have a narrow therapeutic index. If an alternative
cannot be used, exercise caution and consider a dose reduction of
the CYP2D6 substrate. Additionally, abiraterone is a substrate of
CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be
avoided or used with caution.

Use in Specific Populations - The safety of ZYTIGA® in
patients with baseline severe hepatic impairment has not been
studied. These patients should not receive ZYTIGA®.

About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in
Raritan, N.J. and has affiliated facilities in Europe, the United
States and Asia. Janssen Research & Development is leveraging a
combination of internal and external innovation to discover and
develop novel medicines and solutions in five distinct therapeutic
areas: Neuroscience, Oncology, Immunology, Infectious Diseases and
Vaccines, and Cardiovascular and Metabolism. For more information
about Janssen Research & Development, LLC visit
www.janssenrnd.com.

Janssen Research & Development is part of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Driven by our
commitment to patients, we work together to bring innovative ideas,
products, services and solutions to address serious unmet medical
needs around the world.

(This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995.
The reader is cautioned not to rely on these forward-looking
statements. These statements are based on current expectations of
future events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen
Research & Development, LLC and/or Johnson & Johnson. Risks
and uncertainties include, but are not limited to, general industry
conditions and competition; economic factors, such as interest rate
and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges
inherent in new product development, including obtaining regulatory
approvals; challenges to patents; changes in behavior and spending
patterns or financial distress of purchasers of health care
products and services; changes to governmental laws and regulations
and domestic and foreign health care reforms; trends toward health
care cost containment; and increased scrutiny of the health care
industry by government agencies. A further list and description of
these risks, uncertainties and other factors can be found in
Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K
for the fiscal year ended January 1, 2012. Copies of this Form
10-K, as well as subsequent filings, are available online at
www.sec.gov , www.jnj.com or on request from Johnson & Johnson.
Neither Janssen Research & Development, LLC nor Johnson &
Johnson undertake to update any forward-looking statements as a
result of new information or future events or developments.)

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